SCREWINDIRECT DENTAL IMPLANTS


Device Classification Name

implant, endosseous, root-form

510(k) Number K080633
Device Name SCREWINDIRECT DENTAL IMPLANTS
Applicant
IMPLANT DIRECT LLC
27030 malibu hills rd.
calabasas hills, 
CA 
91301

Applicant Contact thomas gottenbos
Correspondent
IMPLANT DIRECT LLC
27030 malibu hills rd.
calabasas hills, 
CA 
91301

Correspodent Contact thomas gottenbos
Regulation Number 872.3640
Classification Product Code
DZE  
Date Received 03/05/2008
Decision Date 07/15/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No